FDA Enforcement
Class II
Ongoing
Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluids.
Recall: Z-1489-2026
·
Reported March 11, 2026
Enforcement
- Recall Number
- Z-1489-2026
- Event ID
- 98240
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Olympus Corporation of the Americas
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 11, 2026
- Initiation Date
- January 29, 2026
- Classification Date
- March 3, 2026
- Address
- 3500 Corporate Pkwy, N/A, Center Valley, PA, 18034-8229, United States
Description
Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluids.
Reason
Potential for rubber fragment detachment during use.
Code Info
Model/Catalog Number: MAJ-1218. UDI-DI: 14953170154291. All Lot Numbers. 20 units per box.
Distribution
US Nationwide distribution.
Quantity
1,276 boxes (20 units per box)